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Gait Analysis and Neuromuscular Function After Primary Total Hip Replacement (RTHA and THA)

This study has been completed.
Sponsor:
Collaborators:
Ministry of the Interior and Health, Denmark
The Danish Rheumatism Association
Odense University Hospital
Information provided by (Responsible Party):
Carsten Jensen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01229293
First received: October 25, 2010
Last updated: September 21, 2012
Last verified: September 2012
History of Changes
  Purpose

This study is conducted at Odense University Hospital(OUH) in collaboration with Institute of Clinical Biomechanics and Sport Science, University of Southern Denmark and Clinical Institute, University of Southern Denmark

Aim: To evaluate the effect of implant design on postoperative total leg muscle function recovery and gait in hip replacement patients.

Design: A prospective randomized controlled clinical trial where patients are randomized into (A) total hip arthroplasty surgery (THA) or (B) resurfacing total hip replacement surgery (RTHA). Pre-surgery assessment and follow-up will be conducted at 8, 26 and 52 wks post-surgery.


Condition Intervention Phase
Osteoarthritis
 Procedure: Articular Surface Replacement (ASR)
Procedure: Standard Total Hip Arthroplasty (THA)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Implant Design on Postoperative Mechanical Muscle Function Recovery and Gait in Hip Replacement Patients: A Randomized Clinical Trail

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Maximal muscle strength (Peak torque, Nm) [ Time Frame: 52 wks post-surgery (primary endpoint) ] [ Designated as safety issue: No ]
    Maximal muscle strength (peak torque, Nm) during maximal voluntary unilateral knee extension-flexion (seated), hip extension-flexion, and hip adduction-abduction (standing), respectively. Both the affected (AF) and non-affected (NA) leg


Secondary Outcome Measures:
  • Rapid force capacity (Rate of torque development, Nm/sec) [ Time Frame: 52 wks post-surgery (primary endpoint) ] [ Designated as safety issue: No ]
    Determined as the mean tangential slope of the torque-time curve in time intervals 0-100ms (RTD100ms), 0-200ms (RTD200ms) and 0-peak (RTD peak) relative to onset of contraction (t = 0ms)

  • Gait parameters [ Time Frame: 26 wks post-surgery (primary endpoint) ] [ Designated as safety issue: No ]
    Selfselected, matched and maximal speed, limb index, Gait deviation index, Movement profile analysis togeter with tempo- spatial parameters

  • Postural Control [ Time Frame: 52 wks post-surgery (primary endpoint) ] [ Designated as safety issue: No ]
    Sway analysis (postural control) during two-leg standing, tandem, one-leg standing and during transistion from sit-to-stand.


Enrollment: 39
Study Start Date: February 2007
Study Completion Date: November 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resurfacing Total Hip Arthroplasty
A hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint. Articular surface replacement ASR, DePuy posterolateral approach used (RTHA)
 Procedure: Articular Surface Replacement (ASR)
Articular surface replacement, DePuy, posterolateral approach used
Active Comparator: Standard Total Hip Arthroplasty (THA)
A standard 28 mm head uncemented THA
 Procedure: Standard Total Hip Arthroplasty (THA)
Device: Biomet 28mm

Detailed Description:

The project consist of three substudies:

  • Determination of test-retest reliability and agreement of specific mechanical muscle function variables for the patients of interest.
  • Evaluate the effect of implant design on postoperative mechanical muscle recovery
  • Evaluate the effect of implant design on postoperative gait
  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary arthrosis

Exclusion Criteria:

  • Osteoporosis, (T-score < 2.5 SD) of proximal femur
  • BMI > 35
  • Severe acetabulum dysplasia (AP centre edge < 15-20°)
  • Femur anteversion > 25°
  • Severe caput deformity
  • Leg length discrepancy > 1 cm
  • Off-set problems
  • Earlier fracture of the ipsilateral proximal femur
  • Rheumatoid arthritis
  • Neuromuscular or vascular disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229293

Locations
Denmark
Orthopaedic Research Unit, Dept. of Orthopaedic Surgery and Traumatology, Odense University Hospital, Inst. of Clinical Research - University of Southern Denmark
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Ministry of the Interior and Health, Denmark
The Danish Rheumatism Association
Odense University Hospital
Investigators
Study Chair: Søren Overgaard, Prof., MD., PhD Odense University Hospital
  More Information

Additional Information:
Orthopaedic Research Unit, Dept. of Orthopaedic Surgery and Traumatology, Odense University Hospital  This link exits the ClinicalTrials.gov site

No publications provided by University of Southern Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Carsten Jensen, PhD-fellow, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01229293     History of Changes
Other Study ID Numbers: VF20050133-2
Study First Received: October 25, 2010
Last Updated: September 21, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Southern Denmark:
Mechanical muscle function
Muscle strength
Hip replacement
Osteoarthritis
Hip arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013